Study of Repotrectinib and CYP450 probe Cocktail in Patients with locally advanced or Metastatic Tyrosine Kinase Inhibitors (TKI)-Pretreated ROS1-Positive Non-small Cell Lung Cancer (NSCLC)
This study is investigating a new medication called repotrectinib for individuals diagnosed with non-small cell lung cancer (NSCLC). Specifically, it's for those whose cancer has a particular change (called ROS1-positive) and has already been treated with similar drugs called tyrosine kinase inhibitors (TKIs). The main goal is to understand how repotrectinib behaves in the human body, including how it's processed and how it might affect other medicines. This early-stage research helps doctors learn more about the drug's safety and how it might work, aiming to improve future treatments for this type of lung cancer. It's an important step in developing new options for patients.
At a glance
What is this study about?
This research study is about a new drug, repotrectinib, being tested for a specific type of lung cancer. The lung cancer it's looking at is called non-small cell lung cancer (NSCLC). This is the most common type of lung cancer. For this study, patients must also have a particular genetic change in their cancer, known as being "ROS1-positive." You might have heard your doctor talk about specific features of your cancer, and ROS1-positive is one such feature that can guide treatment choices.
The study is designed for patients who have already tried other treatments for their cancer, particularly a group of medicines called tyrosine kinase inhibitors (TKIs). These are targeted drugs that work by blocking signals that cancer cells need to grow. The purpose of this study is not primarily to see if repotrectinib cures cancer, but rather to understand how the drug works inside the body, how it's processed, and how it might interact with other medicines. This very early stage of research is sometimes called "human pharmacology."
By taking part, you would be helping doctors learn important information about repotrectinib. This knowledge is crucial for deciding if the drug can be developed further and potentially become a new treatment option for people with ROS1-positive non-small cell lung cancer in the future. It helps us understand the drug's basic behaviour and safety before it can be studied in larger groups of patients to see how well it treats the cancer.
Key takeaways
- This study is for adults with a specific type of non-small cell lung cancer (ROS1-positive).
- It's for people who have already tried other similar cancer treatments (TKIs).
- The main goal is to understand how a new drug, repotrectinib, works in the body and its safety.
- This is an early-stage study (Phase I) helping to develop future cancer treatments.
- Participation involves regular clinic visits for monitoring and receiving the study drug.
Who may be eligible?
This study is open to adults aged 18 and over, with no upper age limit. Both men and women can take part.
You would be considered for this study if you have non-small cell lung cancer (NSCLC) that has spread (metastatic) or is locally advanced (meaning it has grown into nearby areas). Importantly, your cancer must also have a specific marker called "ROS1-positive."
Another key requirement is that you must have already been treated with similar types of cancer drugs known as tyrosine kinase inhibitors (TKIs). This study is for patients whose cancer has not responded well enough to these previous treatments, or if the cancer has come back.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have non-small cell lung cancer that has spread or is locally advanced?
- Has your cancer been identified as 'ROS1-positive'?
- Have you previously received treatment with similar targeted drugs (TKIs) for your cancer?
What does participation involve?
If you decide to take part in this study, you would receive the study drug, repotrectinib, as part of your treatment. The study involves regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how your body is handling the medication. You might also have scans to check your cancer.
Because this is an early-stage study, the exact schedule of visits and tests will be detailed by the study team. It's designed to closely watch how the drug affects you. You would likely have follow-up appointments and continued monitoring for a period after you start the treatment. The total length of your participation would depend on various factors, including how you respond to the treatment, and this would be fully explained by the study doctor.
Potential risks and benefits
Locations (3)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What is ROS1-positive non-small cell lung cancer?
It's a specific type of lung cancer where the cells have a particular genetic change (a ROS1 rearrangement) that can make them grow. This change can sometimes be targeted with specific drugs.
What are TKIs?
TKIs (tyrosine kinase inhibitors) are a type of targeted therapy for cancer. They work by blocking certain signals inside cancer cells that tell them to grow and divide.
Will this drug cure my cancer?
This early-stage study primarily aims to understand how the drug works in the body and its safety, rather than directly assessing if it cures cancer. It's a step towards developing new treatments.
How long will I be in the study?
The duration of your participation will depend on various factors, including how you respond to the treatment. The study team will explain this in detail.
What if I experience side effects?
You would be closely monitored by the study team, and any side effects you experience would be carefully managed and recorded.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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